Validation Specialist

Medial Group; Ponce (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Medial Group in Puerto Rico is seeking a driven professional to lead or support cross-functional teams in equipment and process validation for medical devices. This role emphasizes collaboration across project management, planning, and line management to ensure quality and timely delivery.

The candidate will develop, generate, and execute IQ/OQ/PQ validation protocols, review budgets and schedules, and maintain thorough documentation to meet regulatory expectations.

Qualifications

• Minimum of 2 years of hands-on experience with equipment and process validation in a regulated industry.
• Experience developing and executing IQ/OQ/PQ validation protocols.
• Knowledge of process characterization and validation lifecycle.
• Familiarity with statistical tools for sampling and process evaluation.
• Proven skills in project management and cross-functional coordination.
• Excellent analytical, organizational, and communication abilities.

Responsibilities

• Lead or support cross-functional teams to evaluate, develop, and manage validation projects.
• Oversee operational aspects of ongoing projects and liaise between teams and management.
• Maintain documentation of validation activities, deviations, and reports.
• Ensure compliance with quality, safety, and regulatory standards.
• Monitor project performance and ensure on-time delivery of milestones.

Skills

Cross-functional coordination

Project management

Analytical skills

Strong communication

Statistical data analysis

Regulatory compliance understanding

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

IQ/OQ/PQ

Job description

Ponce, Puerto Rico | Posted on 10/01/2025

Lead or support cross-functional teams to evaluate, develop, and manage projects for new product development and ongoing lifecycle management of products, processes, and therapies.

Oversee and manage operational aspects of ongoing projects, serving as a liaison between project management, planning, project teams, and line management.

Develop, generate, and execute equipment and process validation protocols in compliance with company and regulatory requirements.

Manage the development and implementation process of products and services, focusing on quality, schedule adherence, and project deliverables.

Review project status, budgets, and schedules; prepare status reports and updates for stakeholders.

Monitor project performance from initiation through completion, identifying and resolving issues to meet productivity, quality, and client-satisfaction goals.

Gather and manage requirements to ensure alignment with stakeholder needs and regulatory expectations.

Communicate effectively with stakeholders to ensure engagement and successful delivery of project objectives.

Maintain accurate documentation of validation activities, deviations, and reports.

Ensure compliance with all applicable quality, safety, and regulatory standards.

Other duties may be assigned.

Requirements

Experience: Minimum of 2 years of hands-on experience with equipment and process validation in a regulated industry (medical device, pharmaceutical, or biotechnology).

Technical Skills:

Generation and execution of validation protocols (IQ/OQ/PQ).

Understanding of process characterization and validation lifecycle.

Knowledge of statistical tools for sampling determination and process evaluation.

Proficiency in project management and cross-functional coordination.

Soft Skills: Strong analytical, organizational, and communication abilities; ability to manage multiple priorities and meet deadlines.

Education: Bachelor’s degree in Engineering, Life Sciences, or related field preferred.